Comparison of Basic Regulatory Requirements for Generic Drug Products Registration in CIS and Latin American Countries

Author(s): Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar, Akshay Monga

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 2 , 2020

DOI : 10.2174/2213476X06666191023093840

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Graphical Abstract:


Abstract:

The product registration in the rest of the World is a challenging task because the regions under it are not harmonized. CIS and Latin American regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. Both the regions follow their regional checklist for Drug Product Registration. Latin America includes a group of countries like Brazil, Guatemala and Peru etc, whereas CIS includes Russia, Ukraine, Uzbekistan, Armenia and Tajikistan etc.

Keywords: Generic drug, latin American regions, regulatory requirements, product registration, LATAM region, administrative documents.

[1]
Basak S. Pharmaceutical market and regulatory contents for export of pharmaceutical products to Latin American Countries. IOSR J Pharm 2018; 8(4): 60-72.
[2]
Handoo S, Arora V, Khera D, Nandi PK, Sahu SK. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. Int J Pharm Investig 2012; 2(3): 99-105.
[http://dx.doi.org/10.4103/2230-973X.104392] [PMID: 23373001]
[3]
Xprimm.com. 2019.CIS Countries Available from: http://www.xprimm.com/CIS-Countries-2,12.htm
[4]
Mohak V, Charmy K, Manan S. Regulatory technicalities for drug product registration in Brazil. Int J Drug Regulatory Affairs 2017; 5(4): 18-25.
[http://dx.doi.org/10.22270/ijdra.v5i4.206]
[5]
Sravani M, Kusuma SM, Prabhahar AE, Nadendla RR. Registration of generic drugs in central America and Mexico. Int J Pharm Chem Res 2017; 3(3): 635-50.
[6]
Sri SB, Prabahar AE. current scenario of generic drug regulation and registration process in Latin America Countries. Int J Pharm Chem Res 2017; 3(4): 857-78.
[7]
Choudhary A. Climatic zones for stability studies Pharmaguidelinecom 2019 Available from: https://www.pharmaguideline.com/2010/12/different-climatic-zones-for-stability.html
[8]
Mspcorporate.com. State registration of medicinal products in Russia, drugs registration 2019 Available from: https://mspcorporate.com/registration-medicinal-prod ucts-russia.html
[9]
Badjatya J, Bodla R, Musyuni P. Export registration of pharmaceuticals in rest of world countries (row). J Drug Del Therapeut 2013; 3(1): 61-4.
[http://dx.doi.org/10.22270/jddt.v3i1.391]
[10]
Pharmabiz: Drug registration requirements for various countries Pharmabizcom 2019 [cited: 10 Jan 2019] Available from: http://www.pharmabiz.com/Services/ExportImport/C ountries/Russia.aspx
[11]
State registration of medicinal products in Ukraine Mspua 2019; [cited 10 April 2019] Available from: http://www.msp.ua/registration-medicinal-products-ukraine.html
[12]
Praneetha K, Prakash B, Umasankar K, Alagusundaram M, Jayachandra RP. Study on the regulatory requirements for registration of pharmaceuticals for human use in common wealth of independent states. J Sci 2014; 4(8): 486-504.
[13]
Sate registration of medicinal products in Kazakhstan; [cited 17 Jan 2019] Available from: https://mspcorporate.com/registration-medicinal-products-kazakhstan.html
[14]
State registration of medicinal products in Uzbekistan Mspcorporatecom 2019; [cited 20 Feb 2019] Available from: https://mspcorporate.com/registration-medicinal-products-uzbekistan.html
[15]
Intellectual Property Protection in Eastern Europe | PETOŠEVIĆ Petoseviccom 2019; [cited 26 Feb 2019] Available from https://www.petosevic.com/
[16]
Internet Pharmam. 2019; [cited 12 March 2019] Available from http://www.pharm.am/attachments/article/187/Requirements%20to%20the%20State%20 Registration_2017_ eng_New.pdf
[17]
Scientific center for drug and medical technology expertise after academician E Gabrielyan; [cited 12 March 2019] Available from: http://www.pharm.am/index.php/en/other-documents/187-requirements-to-the-state-registration-of-drugs-in-the-republic-of-armenia


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Article Details

VOLUME: 7
ISSUE: 2
Year: 2020
Page: [117 - 125]
Pages: 9
DOI: 10.2174/2213476X06666191023093840

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